We do a better job testing children's toys than we do medical devices -- and that ain't saying much.
Toys are still being recalled, but at least their makers are now forced to put their products through some basic testing... even if it's only window-dressing. (Read more here.)
With medical devices, there's not even a window, much less a dressing -- because a new study finds that most of the high-risk products recalled in recent years had no testing at all.
And get this: It's because the manufacturers didn't have to test them!
If you want to sell a new artificial joint, defibrillator, ventilator or infusion pump, for example, all you have to do is send the feds a check along with a letter that says, "my device is pretty much just like the other ones already out there" -- even if it's not.
The process is called 510(K), and researchers have found that 71 percent of the 113 high-priority recalls that took place between 2005 and 2009 were approved through this process.
The FDA's response? You're gonna love this. I'm paraphrasing here, but not by much:
"Oh yeah. We already knew all that."
The industry's response was even more outrageous.
Instead of saying any recall of a medical device shows an unacceptable lapse of quality that makes the entire field look bad, the Advanced Medical Technology Association said it wasn't surprised by the news, either.
Since most devices are approved through 510(K), most of the recalls will be 510(K) devices, the trade group told the New York Times.
Really? You guys can't think of a better option here -- like, say, a goal of NO recalls at all, 510(K) or otherwise... much less 113 high-priority ones in just five years?
I guess that's too much to ask.
Maybe someone should check and see if Fisher-Price is interested in making artificial joints and heart defibrillators.
They couldn't do worse!
No test for the wicked,
William Campbell Douglass II, M.D.
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